Business Wire

Pharnext Reports Year End 2016 Financial Results

26.4.2017 16:00 | Business Wire

Del

Regulatory News:

Pharnext SA (Paris:ALPHA) (FR00111911287 - ALPHA), a French biopharmaceutical company developing an advanced portfolio of products in the field of neurodegenerative diseases, today reported its financial and operational results for the year ended December 31, 2016.

2016 KEY EVENTS

Over the course of year, in line with the objectives announced at the time of its IPO, Pharnext rolled out the international Phase 3 trial of its lead clinical candidate PXT3003 for the treatment of Charcot-Marie-Tooth type 1A (CMT1A) disease: patient enrollment was completed in December 2016 as planned (323 patients in total across 3 arms). This pivotal 15-month Phase 3 trial is being conducted at 29 sites including 17 in Europe, 11 in the United States (U.S.) and one in Canada. The first pre-specified evaluation of PXT3003 safety data was conducted in November 2016 by the independent Data Safety Monitoring Board (DSMB). Based on this review, the DSMB recommended continuing the study as planned.

Regarding PXT864, its second lead drug in clinical development for the treatment of Alzheimer’s disease, Pharnext completed the results analysis of its Phase 2a study. The Company was invited to present these promising results during the annual CTAD (Clinical Trials on Alzheimer’s Disease) congress organized in San Diego in December 2016.

Pharnext’s listing on the Euronext Alternext stock exchange in July 2016, a key milestone for the year, enabled the Company to strengthen its equity and its cash by raising 30,9m€. The convertibles bonds held by historic shareholders were converted into equity.

SELECTED FINANCIAL INFORMATION

The main elements of the year-end 2016 financials are set out in the table below: these are taken from the financial statements drawn up under IFRS, which were approved by the Board of Directors at its meeting on April 20, 2017. The audit procedures have been carried out and the auditors’ report relating to the certification of the accounts is in the process of being issued. The full financial statements are available on the Company’s website: www.pharnext.com

Selected financial information (IFRS financial statements)
In kilo euros   2016   2015
Operating Revenues   4 436   2 631
Research and Development expenses (13 647) (7 649)
SG&A expenses (4 177) (3 613)

Operating Income

(13 389) (8 631)

Net Financial Income

(4 058) (2 364)

Earnings before tax

(17 447) (10 994)
Basic earnings per share (in €)   (2,1)   (1,7)

Net cash flows used in operating activities

(12 553) (9 173)

Net cash flows used in financing activities

26 902 5 257

Net cash movement

13 581 (4 148)

Cash and cash equivalents at the end of the period

  16 670   3 089

Operating revenues for the full year of 2016 was mainly generated by the Company’s research tax credit (3,8m€ for the 2016 period) and subsidies.
The increase in Research and development expenses is directly linked to the deployment of the PXT3003 Phase 3 clinical trial.The Financial income is affected, in 2016, by considering, at the level of financial costs, conversion premiums of convertible bond, subscribed in 2014.
Net cash flows used in operating activities were 12,6m€ in 2016: the increase compared to previous period resulted essentially from Phase 3 deployment.
Net cash flows used in financing activities consist mainly, in 2015, of a 5m€ venture loan, and in 2016, of a 2nd tranche of loan of 2.5m€, then of the net proceeds from the issuance of shares during the IPO (28.2m€). In 2016, loan reimbursements and payment of interest charges accounted for 3,5m€.

ANTICIPATED UPCOMING MILESTONES

Over the current financial year, Pharnext is continuing its Phase 3 clinical trial for its drug candidate PXT3003 in CMT1A. The last patient dosed is expected to complete this 15-month pivotal study in March 2018. In between, a futility analysis will be initiated in October 2017. Results of the futility analysis will be published as soon as they will become available.

Beyond the 15-month pivotal study, for which top-line results will be reported during the second quarter of 2018, patients will continue their treatment in a 9-month follow-up extension study designed to assess the long-term safety of PXT3003. This follow-up extension study, which began in March 2017, will continue throughout the year.

In parallel to the above mentioned clinical studies, the Company also initiated new preclinical studies to complement the existing synergy data on PXT3003. At the end of the 15-month pivotal study, if positive, Pharnext plans to submit an application dossier for PXT3003 marketing authorization to the European regulatory authorities (EMA: European Medicine Agency) and U.S. authorities (FDA: Food and Drug Administration).

In addition, after obtaining promising preliminary results in the Phase 2a trial for PXT864 in Alzheimer's disease, the Company will continue the design of the protocol of a Phase 2b study, which is expected to launch by the end of 2017.

Finally, following the signature of a research and development partnership early in March with Galapagos NV, on the creation of a new pipeline of novel synergistic drug combinations, Pharnext plans new agreements with other parties.

Thus, Pharnext is currently in advanced discussion on several international industrial strategic agreements. These agreements would contain business licenses, development of new pipelines and minority investments in equity with a premium on the current stock market price.

About Pharnext

Pharnext is an advanced clinical-stage biopharmaceutical company founded by renowned scientists and entrepreneurs including Professor Daniel Cohen, a pioneer in modern genomics: Pharnext focuses on neurodegenerative diseases and has two lead products in clinical development: PXT3003 is currently in an international Phase 3 trial for the treatment of Charcot-Marie-Tooth disease type 1A and benefits from orphan drug status in Europe and the United States. PXT864 has generated positive Phase 2 results in Alzheimer’s disease. Pharnext is the pioneer of a new drug discovery paradigm: PLEOTHERAPY™. The Company identifies and develops synergic combinations of repositioned drugs at low dose. These PLEODRUG™ offer several key advantages: efficacy, safety and intellectual property including several product or composition of matter patents already granted. The Company is supported by a world-class scientific team.

The company Pharnext is listed on Euronext Alternext Stock Exchange in Paris (ISIN code: FR00111911287).
For more information, visit www.pharnext.com

DISCLAIMER
This press release contains certain forward-looking statements concerning Pharnext and its business. Such forward-looking statements are based on assumptions that Pharnext considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the Document de référence registration document filed with the Autorité des marchés financiers (AMF- French Financial Market Authority) on July 28, 2016 under n°R.16-069 and to the development of economic conditions, financial markets and the markets in which Pharnext operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Pharnext or not currently considered material by Pharnext. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Pharnext to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Pharnext shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

Contact information

Pharnext
Pierre Schwich, +33 (0)1 41 09 22 30
Chief Financial Officer
investors@pharnext.com
or
Investor Relations (Europe)
MC Services AG
Anne Hennecke, +49 211 529252 22
anne.hennecke@mc-services.eu
or
Media Relations (Europe)
ALIZE RP
Caroline Carmagnol
Margaux Pronost
+33 (0)1 44 54 36 64
pharnext@alizerp.com
or
Investor Relations (U.S.)
Stern Investor Relations, Inc.
Sarah McCabe, +1 212-362-1200
sarah@sternir.com
or
Media Relations (U.S.)
Russo Partners
Tony Russo, Ph.D.
Scott Santiamo
+1 212-845-4251
+1 212-845-4235
tony.russo@russopartnersllc.com
scott.Santiamo@russopartnersllc.com
or
Investor Relations (France)
NewCap
Julie Coulot, +33 (0)1 44 71 20 40
pharnext@newcap.eu

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Meggitt Training Systems to Exhibit at DSEI 201722.8.2017 14:00Pressemelding

Meggitt Training Systems, the leading provider of integrated live-fire and virtual weapons training products and services for armed forces and law enforcement, will participate at Defence and Security Equipment International (DSEI) through the Georgia Department of Economic Development. The military and security industry event will be held September 12-15, 2017 at ExCeL in London, England. “Today’s threats necessitate maximum realism, despite stretched budgets, and that’s what Meggitt provides to government and commercial customers globally,” said Mark Mears, managing director at Meggitt Training Systems, Ltd. “Although proudly based in Georgia, Meggitt Training Systems is part of Meggitt PLC, a UK-headquartered corporation. As such, we particularly look forward to engaging with current and prospective customers at DSEI, the UK’s largest defense and security trade show.” On

SailPoint Named a Leader in Cloud-based Identity Governance22.8.2017 14:00Pressemelding

SailPoint, the leader in enterprise identity management, was recently named the overall market leader in KuppingerCole’s 2017 “Leadership Compass: Identity as a Service: Cloud-based Provisioning, Access Governance and Federation.” In addition to being named a leader in every category of the report, SailPoint received superior rankings in four of the five evaluation criteria: security, functionality, interoperability and usability. KuppingerCole is an international and independent analyst organization with a strong focus on Information Security and Identity and Access Management. KuppingerCole’s Leadership Compass reports provide an in-depth analysis of the main players in the market, defining each as a follower, challenger or leader. The Leadership Compass Report for IDaaS evaluates leaders in innovation, product features, and market reach for identity-as-a-service offerings tar

Camelbay Real Estate Management NL B.V. Selects Yardi Voyager22.8.2017 13:58Pressemelding

Camelbay Real Estate Management NL B.V. will utilise Yardi Voyager® 7S, a browser-agnostic, fully mobile Software-as-a-Service platform, as its accounting and property management platform. Camelbay will use Yardi Voyager to streamline its property management, leasing and accounting processes for its Dutch real estate portfolio, which is predominantly comprised of commercial office assets. “The automation, transparency and fully integrated accounting and property management that Voyager provides will help us manage our daily financial and operational activities more efficiently and enhance our competitive position within the Dutch office market,” said Alon Levy, Director of Camelbay Real Estate Management NL B.V. “We are very pleased to welcome Camelbay as our latest client in the Netherlands,” said Neal Gemassmer, Vice President of International for Yardi.

Laser Design CyberGage®360, Automated 3D Scanning & Inspection System Adopted by Proto Labs in their State-of-the-Art Metrology Lab22.8.2017 13:44Pressemelding

Laser Design, Inc., a subsidiary of CyberOptics (NASDAQ:CYBE), and premier provider of ultra-precise 3D scanning systems and services, announces the adoption of the CyberGage360 3D Scanning and Inspection system by Proto Labs, the world’s fastest digital manufacturing source for custom prototypes and low-volume production parts providing unprecedented speed-to-market value for designers and engineers. “At Proto Labs, we strive to challenge the traditional rules of manufacturing in order to deliver custom manufactured components at unprecedented speeds,” said Dylan Lundberg, Senior Manufacturing Engineer of Protoworks, Proto Labs’ R&D lab. “Everything we do revolves around reducing our customers’ time to market and we do that by digitalizing the entire manufacturing process. From our front-end services to our proprietary processes on the manufacturing floor, you will find thr

Altierre Strengthens Executive Team in Europe With Hiring of Guillaume Vicot and Niclas Qvist22.8.2017 12:00Pressemelding

Altierre Corp., a provider of the world’s highest density, ultra-low energy, long-range wireless technology and applications for the Internet of Things (IoT) market, today announced two additions to its France-based European executive team. Guillaume Vicot has joined the company as General manager, Europe, Middle East and Asia (EMEA) and Niclas Qvist has joined as Vice President, Partner management & Marketing. Vicot joins Altierre’s management team after 17 successful years in the Auto-ID industry, barcode scanning and mobile computing. He most recently served as Vice President of sales, Western Europe, for PSC / Datalogic, leader in the bar code scanning industry, where he oversaw a team of more than 100 people and developed a tactical go-to-market strategy, achieving revenue well over US$100 million. “Guillaume has many top level strategic relationships with retailers

IFF to Present at the Barclays Global Consumer Staples Conference21.8.2017 20:15Pressemelding

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris:IFF), a leading innovator of sensory experiences that move the world, today announced that Andreas Fibig, Chairman and Chief Executive Officer will present at the Barclays Global Consumer Staples Conference in Boston, MA on Thursday, September 7, 2017 at 11:15 a.m. EDT. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Meet IFF International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris:IFF) is a leading innovator of sensorial experiences that move the world. At the heart of our company, we are fueled by a sense of discovery, constantly asking “what if?”. That passion for explorati

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom